The FDA warning letter is getting the labor force to work with a high risk because of the high demand of the products and the managers do not walk in the floor and this leads to accidents and procedures not followed or documented properly and it continues this behavior for the past five years and the general manager has been changed because he last one did not Adress on time the emergency or urgency of doing production but at a high risk or GMP non interest from the management.
The management says we will follow the procedures but they don’t go to the floor to see if the documents are being followed properly and then the management tries to be like Hitler and do not observe that the machines do not have spare parts and not enough work force employees and people have not been substitute or replaced once somebody leaves.
Or train new resources,
Definitely investing the money is not profitable if you don’t watch over your business or parts needed for documents being done correctly or just saying thank you to your employees once things are achieve correctly without being in your desk asking for your people to do things when you are there to serve them and then your people will gladly service you.
The structure needs a full new organization and people needs to be cleaned out of the house with old mentality.
